BEUDAMED
    FDA Adverse Event Summary report: N

    BOUNDER

    MDR report key: 201459 · Received December 8, 1998

    Report

    Report Number
    2027797-1998-00002
    Date Received
    December 8, 1998
    Date of Event
    November 20, 1998
    Report Date
    December 2, 1998
    Manufacturer
    21ST CENTURY SCIENTIFIC, INC.
    Product Code
    ITI
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER WAS SITTING IN A BOUNDER WHEELCHAIR WHEN THE RIGHT ARM GAVE WAY. HE FELL OUT OF THE CHAIR, HITTING HIS HEAD AND SUSTAINING BURNS FROM THE MOTOR. PRELIMINARY EVALUATION BY THE DEALER INDICATES THAT THE REAR ARM BRACKET WAS KNOCKED LOOSE - - PROBABLY FROM SOME SORT OF BLOW OR COLLISION. THIS WEAKENED THE BRACKET CONNECTION AND WHEN THE USER LEANED ON THE ARM, IT GAVE WAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOUNDER POWER WHEELCHAIR ITI 21ST CENTURY SCIENTIFIC, INC. BOUNDER *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization